I'm to blame for failings, says drug factory boss

The executive responsible for the drug factory that was shut down for being in a "disgraceful state of disrepair" admitted yesterday that he had failed to ensure standards were met but dismissed any health or safety concerns.

"It's a combination of failures," said David Young, managing director of Australian Pharmaceutical Industries (API), the parent company of Soul Pattinson Manufacturing, whose Kingsgrove plant was closed by API to rectify manufacturing breaches revealed in a surprise Therapeutic Goods Administration (TGA) audit.

" I'm accountable for the business and I think that we failed as managers in ensuring we didn't need to do this [shut down the factory]," Mr Young said.

He conceded that management had been preoccupied with searching for a new factory site for the past two years and had failed to keep up maintenance.

But he was at pains to distance the shutdown from the recent Pan Pharmaceuticals scandal, which led to Australia's biggest medical recall.

On Tuesday, the plant suspended manufacture of more than 900 products, mainly over-the-counter medicines, for six weeks after the TGA found it was run-down, had inadequate quality control, paint flaking off the ceiling and holes in floors.

API supplies products to many pharmacies, including the Soul Pattinson shops, all of which are independently owned, except for one in Pitt Street, Sydney.

The TGA said yesterday that an audit in August 2001 found signs of deterioration, but after a follow-up four months later it believed these had been addressed.

A spokeswoman said the TGA would have suspended production if API had not.

Asked why it had taken two years to audit the plant again, she said the original problems did not require any immediate regulatory action.

Mr Young said the TGA had tested a sizeable sample of the factory's products and found no unsafe or incorrectly formulated products. However, one range of antihistamine containing promethazine hydrochloride, sold under six brands, had been withdrawn from sale.

He said the TGA accepted there were no health concerns over the product, but that its "three-year shelf life was questionable".

API agreed to start retesting raw ingredients last week, he said, but he denied the plant was in a "disgraceful" state, as asserted by the TGA.

The company had been working on improving its internal control processes since July.

The audit report into the factory is believed to have found some areas of the plant were "extremely dirty" and could harbour "micro-organisms".

The Herald understands that the report mentioned rotting wooden floors and that flaking paint off the ceiling could "potentially contaminate" products.

There were floor and wall joints that were impossible to clean and cracked vinyl that could harbour micro-organisms.

No records were found of cleaning procedures, the report is believed to state.